Effects of Mode of Anaesthesia on Circulating Tumour Cells in Patients Undergoing Inhalational Versus Total Intravenous Anaesthesia for Hepatocellular Carcinoma Surgery : A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- HIF-1 gene expression
研究概览
简要总结
More than 80% of patients with cancer will be exposed to anaesthesia at some point in their treatment. There is increasing evidence that perioperative events, including the type of anaesthesia drugs utilised, have an impact on cancer recurrence and metastases.
Although potentially and theoretically curative, surgical resection, manipulation and trauma may disseminate tumour cells and reduce immunity. There have been a number of suggestions as to why cancer may be, paradoxically, worsened by surgery and what methods may be used to mitigate this. One of these is propofol based total intravenous anaesthesia (TIVA), whereby the traditional inhalational anaesthetic drugs are avoided. Commonly used inhalational drugs, such as sevoflurane and desflurane, are pro-inflammatory.
Propofol, however, has anti-inflammatory and anti-oxidative properties, induces apoptosis and has specific inhibitory effects on tumour cell growth in vitro. Laboratory investigations, animal models, retrospective clinical studies and initial clinical research are producing evidence that inhalational anaesthesia facilitates tumour recurrence and metastasis, whilst TIVA can prolong survival.
This randomised, controlled trial will look at the effects on DNA damage and biomarkers of immunity and inflammation of inhalational anaesthesia versus TIVA in patients undergoing surgery for hepatocellular carcinoma, a common tumour in the Southern Chinese population, for whom surgery is potentially-curative. It will focus on subjects undergoing open and laparoscopic hepatectomy and investigate changes in biomarkers of inflammation, immunity and gene expression from the patients' blood samples taken before, during and after surgery.
Patients will also be followed-up for cancer recurrence, morbidity and five-year mortality. Results could represent a breakthrough in knowledge of how anaesthetic agents impact the results of cancer surgery, and have important implications for a more disease- sensitive approach to improving management and outcomes in these patients.
详细描述
Pre-operative care
Pre-operative assessment will be performed at the preadmission clinic or at the general ward. Patients will be fasted for intake of solid food for 6 hours and clear liquids for 2 hours. Sedative premedication will not be prescribed.
Anaesthesia and intraoperative care
SEVO Group
Patients from the SEVO group will be anaesthetized according to the following protocol:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 18-80 years old with primary hepatocellular carcinoma presenting for elective open hepatectomy surgery in Queen Mary Hospital, Hong Kong, will be invited to join this randomised, controlled trial.
排除标准
- •Pre-operative factors
- •Contraindication to general anaesthesia
- •Autoimmune / Chronic inflammatory diseases e.g. Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis(RA) etc.
- •Chemotherapy in the past year
- •Steroid therapy
- •Surgery for tumour removal in the past year
- •patients post liver transplantation Intra-operative factors
- •Regional Anaesthesia
- •Administration of:
- •Nitrous oxide
- •Inhalational agents (with the exception of sevoflurane)
研究组 & 干预措施
SEVO Group
Patients in SEVO group will be anaesthetized by inhalational anaesthesia using sevoflurane.
干预措施: Sevoflurane (Drug)
TIVA group
The patients in TIVA group will be anaesthetized using total intravenous propofol.
干预措施: Propofol (Drug)
结局指标
主要结局
HIF-1 gene expression
时间窗: 24 hour
the detection of a two-fold difference between the pre-operative blood sample and 24-hour post-operative blood sample in HIF-1 gene expression in the SEVO group, and a less than two-fold difference in the same samples of the TIVA group
次要结局
- Change in number of recurrence(2 year)
- Level of Gene expression(Pre-operative, Intra-operative, Immediately post-operative and 24 hours post-surgery)
- Level of DNA damage(Pre-operative, Intra-operative, Immediately post-operative and 24 hours post-surgery)
- Level of Superoxide dismutase(Pre-operative, Intra-operative, Immediately post-operative and 24 hours post-surgery)
- Level of Oxidative damage DNA(Pre-operative, Intra-operative, Immediately post-operative and 24 hours post-surgery)
- Level of tumor necrosis factor(Pre-operative, Intra-operative, Immediately post-operative and 24 hours post-surgery)
- Number of Circulating tumour cells(Pre-operative, Intra-operative, Immediately post-operative and 24 hours post-surgery)
- Level of C-reactive protein(Pre-operative, Intra-operative, Immediately post-operative and 24 hours post-surgery)
- Level of Glutathione Peroxidase(Pre-operative, Intra-operative, Immediately post-operative and 24 hours post-surgery)